IACUC Policy and Procedures
The Institutional Animal Care and Use Committee (IACUC) is appointed by the Provost of the university to ensure compliance with Federal regulations (Department of Agriculture 9 CFR parts 1 and 2; Public Health Service 99-158) concerning care and use of vertebrate animals in research and teaching activities. Any type of activity involving live vertebrate animals must be approved by the IACUC Committee prior to acquisition of animals or initiation of any research or laboratory exercise. Projects which may involve such activities include but are not limited to grant proposals, laboratory class exercises, thesis/dissertation research, and independent laboratory research.
Questions can be directed to the W&M Research Compliance at researchcompliance@wm.edu.
Animal Welfare concerns should be reported to reportconcern@wm.edu. All reports are confidential.
There is no restriction on who may report a concern. Despite the reporting method, per The Guide, 8th edition (p.23-24), the "Responsibility for review and investigation of these concerns rests with the IO (Institutional Official) and the IACUC."
Protocol Review Process
For every project involving vertebrate animals, the principal investigator(s) is required to use the SPARCS IACUC online submission program.
Period of Approval
Projects and protocols are approved for the anticipated duration of the activity, up to a maximum period of three years, with a requirement for annual review. If you would like to continue research with the protocol past the three-year renewal period, a De Novo Review will be submitted to extend the protocol's approval dates. Each renewal submission must include a current search for alternative methods.
Once protocols are approved, please post the Emergency Contact Form on the lab's door.
Continuing (Annual) Reviews
Should projects extend longer than one year from the date of initial approval, materials must be submitted to the IACUC for annual review through the SPARC IACUC system up to 4 weeks before the review/expiration date to allow processing time.
Requests for Protocol Modification (Amendments)
Changes to a protocol must be submitted using the SPARCS system and approved by IACUC before implementation of any modification to a protocol. Included under this policy are changes in personnel. The purpose of these reviews is to ensure the university remains in compliance with the Animal Welfare Act including the provision of necessary training of personnel.
NOTE: Submitting a continuing review does not replace the amendment process and vice versa. If you would like to make changes to you protocol at your continuing (annual) review, an amendment and continuing review must be submitted. These processes can be done simultaneously.
OLAW Guidance on Animal Care
Training
All personnel working with live vertebrates must receive sufficient training in all procedures in which they will participate to ensure that animals are properly cared for and maintained. New faculty, staff, and students are required to complete the CITI IACUC modules, along with any other applicable species or technique modules before beginning work with animals. Student and staff training will be supplemented by the principal investigator who is responsible for maintaining his/her own training level.
The Adjunct and Associate Adjunct Veterinarians will provide training, as needed, to any investigator who wishes to engage in surgical techniques with which they are unfamiliar. It is the principal investigator's responsibility to maintain training records for themselves and any other participants working under their approved protocol. Training records must be provided for inspection by any oversight authority including the IACUC.
Facility Inspections
There are three types of facility inspections performed during the course of each year. Each type of inspection has a specific purpose.
- APHIS Veterinarian Inspection.
- The USDA APHIS Veterinarian makes one or more unannounced inspections during the course of each year. The purpose of the inspections is to verify that the IACUC is properly overseeing the use of animals in research and teaching.
- The IACUC may be cited during the course of such inspections because of deficiencies observed in the laboratory facilities or for various aspects of committee operation, especially record-keeping.
- Investigators may be contacted during this visit by the IACUC Office to ensure that someone is present in each laboratory during such visits. Whenever possible, the IACUC Chair will be present during part or all of these visits.
- Following receipt of the inspector's report, the IACUC Chair will notify appropriate investigators of any citations requiring corrective action by an investigator and include a time limit for such correction.
- Failure to correct a deficiency can lead to IACUC withdrawal of authorization to continue work so as to protect the university and other investigators from being denied the authority to conduct research by the federal regulatory agencies.
- Announced IACUC Inspections.
- The IACUC will make announced semiannual inspections following its semiannual meetings.
- These inspections will occur on William & Mary campus on the day of the meeting, or within one week of the date of the meeting, as appropriate.
- The VIMS campus inspections will be conducted on the same day, or within one week of that day (unless notice is given in advance changing this schedule).
- Inspections at each facility, conducted in accordance with The Guide, involve the veterinarian and at least one member of the committee (preferably the Chair), who is not a member of the facility staff or the PI.
- At least two times per year, the Adjunct Veterinarian or his/her associate and the IACUC Chair or his/her designee will perform unannounced inspections of all facilities.
- The purpose of these inspections is to confirm that appropriate veterinary care is being provided to all animals; that proper sanitation, feeding, housing, etc. are being provided; and that approved protocols are being followed.
- The inspections are intended to be supportive of investigators, not punitive, by providing an independent evaluation of animal conditions leading to corrective action when appropriate.
Semi-Annual Meetings
The IACUC will hold semiannual meetings in the spring and fall in accordance with the Assurance Statement of the university and the Animal Welfare Act and associated regulations.
Reports of Animal Abuse
- Any member of the W&M community who has specific concerns about the handling of animals in a particular protocol has the right, and the obligation, to submit their concern in writing to the Institutional Officer, the Chair of the IACUC, the Adjunct Veterinarian, or other Committee members. The university also makes available an email address, reportconcern@wm.edu, to enable reporting.
- Report Process
- Upon notification of a concern, the IACUC Chair along with the Adjunct Veterinarian, will initiate an investigation of the situation.
- They will report the allegation and their initial findings to the members of the Committee at a specially called meeting.
- The investigator involved will be invited to attend the meeting to present his/her view of the issue.
- The committee will then enter into a closed session to resolve the validity of any allegation and to determine the appropriate action. Such action may include a resolution that the allegation is unfounded, a change in protocol to eliminate the cause of concern, or in extreme cases, termination of a protocol.
- Results of the deliberation will be provided to the investigator and to the person making the initial allegation.
- In accordance with the Animal Welfare Act and the Assurance Statement of the university, all such proceedings will be reported in full to the responsible federal agencies.
The Three Rs
The IACUC endorses the application of the 3 Rs ( Reduction, Replacement and Refinement) concept to the minimization of pain and distress in animals.
- Reduction refers to reducing the number of test animals to the minimum consistent with the production of reliable information.
- Replacement (also known as alternative methods) refers to the substitution of alternative living or non-living models for certain research (substitution of invertebrate species for vertebrate species or use of in vitro methods in place of in vivo methods.).
- Refinement refers to any means used to decrease the incidence or severity of pain and distress in research animals. All three elements of the concept must be addressed in protocol submissions to the IACUC.
Multiple survival surgeries
Multiple survival surgeries on individual animals require explicit approval by IACUC. In general, multiple survival surgeries are discouraged but may be performed when necessary to complete a particular experiment and with appropriate safeguards.
Identification of Animals
All animal housing must be tagged with the protocol number to include the current annual review date and investigator's name, under which the activity is being maintained. Those animals that have been subjected to surgical treatments should be identified. Breeding animals should be identified appropriately to track lineage.
Policy regarding ascites production
Monoclonal antibodies are commonly produced from an ascites tumor induced in a mammal such as a mouse. The deliberate induction of a tumor, which in itself produces pain in the animal host, and various procedures often used to harvest repeatedly the antibody are considered to be inhumane. If there are no alternative techniques for the production of antibodies, use of this technique can clearly be justified by a sufficient expression of need alone. Although alternative in vitro techniques have been developed, there is presently no clear consensus concerning the balance of advantages and disadvantages of in vitro versus in vivo methods. Therefore, at this time, it is reasonable to continue the use of ascites tumors to produce monoclonal antibodies provided there is ample scientific justification to warrant this use of animals. Until such time as there is a consensus concerning in vitro techniques, it shall be the policy of the IACUC that:
Investigators who propose the production of monoclonal antibodies through ascites production are required to justify use of this technique over any of the available in vitro techniques or purchase of the monoclonal antibodies from a "core facility" such as that at The Johns Hopkins University where in vitro techniques are used. With proper scientific justification, the committee will continue to approve, on a case by case basis, protocols that include monoclonal antibody production from mouse ascites.
Special Activities
In some cases, it is necessary to maintain unique conditions as a part of a research protocol, e.g., photo-periods, radiation treatments, immuno-suppression. If such a laboratory area is not properly identified, and entry is made inappropriately, responsibility shall rest with the investigator not the inspecting authority.
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